RECRUITING

Opioids, Low Nicotine Cigarettes, and Chronic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the effects of switching to very low nicotine content (VLNC) cigarettes versus normal nicotine content (NNC) cigarettes on craving, withdrawal, and pain among individuals with chronic pain who smoke cigarettes daily and are attending office-based buprenorphine treatment (OBBT).

Official Title

Targeting Reinforcement Mechanisms for Smoking Cessation Using Very Low Nicotine Content Cigarettes in Individuals With Opioid Use Disorder and Chronic Pain

Quick Facts

Study Start:2025-04-15
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06747871

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 21+ years who smoke cigarettes daily
  2. * Chronic non-cancer musculoskeletal pain secondary to structural changes (e.g., low back pain, osteoarthritis)
  3. * Have received stable office-based buprenorphine treatment for opioid use disorder for at least 30 days
  4. * Self-report smoking at least 10 cigarettes/day
  5. * Expired breath carbon monoxide (CO) level \>8 ppm
  6. * Have a smartphone capable of running software for ecological momentary assessment
  7. * Open to exploring the possibility of quitting smoking
  1. * Pain specifically due to cancer
  2. * Other significant health problems
  3. * Major surgery within the past 6 months or planned surgery within the timeframe of the study
  4. * Current disability litigation
  5. * Use of electronic cigarettes or other non-cigarette tobacco products \> 9 of the past 30 days
  6. * Current use of nicotine replacement therapy or other cessation treatment
  7. * Current daily or near-daily cannabis use
  8. * History of psychotic disorder
  9. * Acute suicidality or current unstable psychiatric disorder
  10. * Positive pregnancy test
  11. * Actively seeking smoking cessation treatment

Contacts and Locations

Study Contact

Clinical Research Coordinator
CONTACT
919-907-9955
ta141@duke.edu
Clinical Research Coordinator
CONTACT
984-327-6157
lgf12@duke.edu

Principal Investigator

Maggie Sweitzer, PhD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

North Pavilion
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Duke University

  • Maggie Sweitzer, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Pain
  • Tobacco Use
  • Opioid Substitution Treatment